Axsome Therapeutics antidepressant drug could become blockbuster

An analyst is predicting that Axsome Therapeutics’ novel antidepressant therapy, which was granted Priority Review by FDA on April 26, will become a blockbuster drug.

AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist with multimodal activity to treat major depressive disorder (MDD), Axsome said in a press release.

“In clinical trials, AXS-05 has demonstrated rapid and sustained anti-depressive effects, which will enable it to meet some of the key unmet needs that exist in the major depressive disorder (MDD) market for more effective therapies, as well as for therapies with a rapid onset of action,” said Philippa Salter, neurology analyst for GlobalData in a press release. As a result, GlobalData expects “strong uptake” of AXS-05 when it reaches the market.

FDA previously granted Breakthrough Therapy Designation for AXS-05 for the treatment of MDD in March 2019. The FDA also granted Breakthrough Therapy Designation for AXS-05 for a second indication, Alzheimer’s disease agitation, in June 2020.

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Axsome’s new drug application for AXS-05 is supported by results from two randomized, double-blind, controlled trials of AXS-05 in patients with a confirmed diagnosis of moderate to severe MDD, which demonstrated statistically significant improvements in depressive symptoms with AXS-05 compared to placebo and active controls, respectively, Axsome said.

AXS-05 will have the potential to become a blockbuster drug by 2026 and will boast global sales of around $1.3 billion by 2029, data and analytics firm GlobalData predicts.

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However, AXS-05 is unlikely to become a first-line therapy for MDD, according to Salter. “The current first-line therapies, such as the selective serotonin reuptake inhibitors (SSRIs) and the serotonin-norepinephrine reuptake inhibitor (SNRIs), are very well entrenched in the market and have the advantage of being available as cheap generics, making it challenging for new, more expensive therapies to compete.”

The major depressive disorder (MDD) market is expected to grow from $3.97 billion in 2019 to $7.87 billion by 2029 across eight major markets — US, France, Germany, Italy, Spain, UK, Japan, and Canada — GlobalData said in a separate report, Major Depressive Disorder – Global Drug Forecast and Market Analysis to 2029,

The main driver of growth will be the launch of eight new pipeline products throughout the eight major markets, GlobalData said.

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